Patient-specific neuromodulation alignment structures

ABSTRACT

The present discussion relates to structures and devices to facilitate application of an ultrasound therapy beam to a target anatomic region in a replicable manner. In certain aspects, adjustable positioning structures are described that allow a general probe positioning structure to be configured for a specific patient in a manner that allows the device to be used repeatedly to target the anatomic region, even when in non-clinical settings. In other aspects, a probe positioning structure is fabricated that is specific to a respective patient anatomy, such that use of the probe positioning structure provides repeatable targeting of the target anatomic region, even when in non-clinical settings.

BACKGROUND

The subject matter disclosed herein relates to targeting and/or dosingregions of interest in a subject via application of neuromodulatingenergy to cause targeted physiological outcomes. In particular, thedisclosed techniques may be useful in helping an untrained personprovide repeated treatments to a targeted region.

Neuromodulation has been used to treat a variety of clinical conditions.However, specific tissue targeting via neuromodulation may bechallenging. For example, accurate focusing of neuromodulating energymay vary based on individual patient anatomy. Certain patients may havevariations in organ size or location relative to other patients based ontheir height, weight, age, gender, clinical condition, and so forth,which may impact targeting and dose delivery when using variousneuromodulation techniques.

In the context of neuromodulation using ultrasonic devices, other commonchallenges may relate to the difficulty in repeatedly deliveringaccurate and consistent ultrasonic therapy at a prescribed dose in thecontext of a treatment regime involving multiple, repeated treatments ofthe treatment region. Further such treatments may be difficult for aminimally trained person to administer, making it necessary for thepatient to enter a clinical setting and/or be treated by medicallytrained personnel for each treatment session. Treatment by the patientthemselves, or in a home setting, is therefore not typically consideredfeasible for an ultrasound-based neuromodulation regime.

For example, when a clinician administers a conventional ultrasoundexam, the clinician places the probe on the body and maneuvers in alldegrees-of-freedom (DOFs) until they arrive at the target scan plane. Incontrast, in a patient or self-administered, at-home context, theuntrained user has near zero capacity to understand an ultrasound image,even if available, and intelligently maneuver a handheld ultrasoundprobe to find the target. Such issues make self-administration ofprecisely targeted ultrasonic based treatments, particularly in anat-home context, impractical using conventional approaches.

BRIEF DESCRIPTION

The disclosed embodiments are not intended to limit the scope of theclaimed subject matter, but rather these embodiments are intended onlyto provide a brief summary of possible embodiments. Indeed, thedisclosure may encompass a variety of forms that may be similar to ordifferent from the embodiments set forth below.

In one embodiment, a wearable device is provided. In accordance withthis embodiment, the wearable device comprises an ultrasound probe and apositioning structure configured to hold the ultrasound probe. Theultrasound probe comprises one or more ultrasound transducers. One ormore of the ultrasound transducers are configured to emit a therapy beamand one or more of the ultrasound transducers are configured to emit animaging beam.

In another embodiment, a method of configuring a wearable device isprovided. In accordance with this embodiment, the wearable device isapplied to a subject. An ultrasound probe is coupled to a positioningstructure of the wearable device. The ultrasound probe comprises one ormore ultrasound transducers. One or more of the ultrasound transducersare configured to emit a therapy beam and one or more of the ultrasoundtransducers are configured to emit an imaging beam. One or more of thewearable device, the positioning structure, or the ultrasound probe areadjusted with respect to an anatomic target region of the subject. Oneor more fitting parameters of the wearable device, the positioningstructure, or the ultrasound probe, when aligned to the anatomic targetregion, are determined. The one or more parameters are saved for usewhen the wearable device is subsequently applied to the subject for atherapy session.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood when the following detaileddescription is read with reference to the accompanying drawings in whichlike characters represent like parts throughout the drawings, wherein:

FIG. 1 is a block diagram of a neuromodulation delivery system accordingto embodiments of the disclosure;

FIG. 2 depicts a wearable structure suitable for use as an ultrasoundprobe positioning structure, in accordance with aspects of the presentdisclosure;

FIG. 3 depicts a further view of a wearable structure suitable for useas an ultrasound probe positioning structure, in accordance with aspectsof the present disclosure;

FIG. 4 depicts an example of a probe holder for use with an ultrasoundprobe positioning structure, in accordance with aspects of the presentdisclosure;

FIG. 5 depicts a cut-away view of the probe holder of FIG. 4, inaccordance with aspects of the present disclosure;

FIG. 6 depicts examples of probe caps for use with an ultrasound probepositioning structure, in accordance with aspects of the presentdisclosure;

FIG. 7 depicts a wearable structure suitable for use as an ultrasoundprobe positioning structure, in accordance with aspects of the presentdisclosure;

FIG. 8 depicts a wearable structure suitable for use as an ultrasoundprobe positioning structure, in accordance with aspects of the presentdisclosure;

FIG. 9 depicts a probe module having surface features and suitable foruse with an ultrasound probe positioning structure, in accordance withaspects of the present disclosure;

FIG. 10 depicts a wearable structure suitable for use as an ultrasoundprobe positioning structure, in accordance with aspects of the presentdisclosure;

FIG. 11 depicts a wearable structure suitable for use as an ultrasoundprobe positioning structure, in accordance with aspects of the presentdisclosure;

FIG. 12 depicts a wearable structure suitable for use as an ultrasoundprobe positioning structure, in accordance with aspects of the presentdisclosure;

FIG. 13 depicts a sequence of cartoons illustrating application of thewearable structure of FIG. 12 to a patient, in accordance with aspectsof the present disclosure;

FIG. 14 depicts a probe holder pocket suitable for holding a probemodule with respect to an ultrasound probe positioning structure, inaccordance with aspects of the present disclosure;

FIG. 15 depicts a process flow illustrating steps in fitting anultrasound probe positioning structure, in accordance with aspects ofthe present disclosure;

FIG. 16 depicts isoangle contours derived for multiple probe andwearable structure combinations, in accordance with aspects of thepresent disclosure;

FIG. 17 depicts a process flow illustrating steps in fabricating acustom fitted fixture using surface profilometry and additivemanufacturing, in accordance with aspects of the present disclosure;

FIG. 18 depicts a process flow illustrating steps in fabricating acustom fitted fixture using thermoformable materials, in accordance withaspects of the present disclosure;

FIG. 19 depicts a process flow illustrating steps in fabricating acustom fitted fixture using casting techniques, in accordance withaspects of the present disclosure;

FIG. 20 depicts a sealing ring, in accordance with aspects of thepresent disclosure;

FIG. 21 depicts a molded body impression, in accordance with aspects ofthe present disclosure;

FIG. 22A depicts a transducer mounting plate, in accordance with aspectsof the present disclosure;

FIG. 22B depicts an additional transducer mounting plate, in accordancewith aspects of the present disclosure; and

FIG. 23 depicts an exploded view of aspects of forming a custom fittedfixture, in accordance with aspects of the present disclosure.

DETAILED DESCRIPTION

One or more specific embodiments will be described below. In an effortto provide a concise description of these embodiments, not all featuresof an actual implementation are described in the specification. Itshould be appreciated that in the development of any such actualimplementation, as in any engineering or design project, numerousimplementation-specific decisions must be made to achieve thedevelopers' specific goals, such as compliance with system-related andbusiness-related constraints, which may vary from one implementation toanother. Moreover, it should be appreciated that such a developmenteffort might be complex and time consuming, but would nevertheless be aroutine undertaking of design, fabrication, and manufacture for those ofordinary skill having the benefit of this disclosure.

Any examples or illustrations given herein are not to be regarded in anyway as restrictions on, limits to, or express definitions of, any termor terms with which they are utilized. Instead, these examples orillustrations are to be regarded as being described with respect tovarious particular embodiments and as illustrative only. Those ofordinary skill in the art will appreciate that any term or terms withwhich these examples or illustrations are utilized will encompass otherembodiments that may or may not be given therewith or elsewhere in thespecification and all such embodiments are intended to be includedwithin the scope of that term or terms. Language designating suchnon-limiting examples and illustrations includes, but is not limited to:“for example,” “for instance,” “such as,” “e.g.,” “including,” “incertain embodiments,” “in some embodiments,” and “in one (an)embodiment.”

As discussed herein, one issue that can arise with respect to therapytechniques that involve multiple sessions (e.g., lx per day, 3× perweek, lx per week) of targeted ultrasonic neuromodulation is the need toprovide consistent, correct alignment for each session. In the contextof a therapy capable of being implemented in non-clinical settings(e.g., at home) by individuals with little or no medical training(including patients) it is desirable that such targeting and alignmentguidance be provided in as simple a format as possible. For example, itmay be desirable to provide targeting and/or alignment assistancewithout manual guidance based on displayed images and/or with commonsources of user error or frustration removed or minimized. In addition,it may further be useful to use one type of alignment device that issuitable for use across a wide patient population, despite the fact thata “one size fits all approach” is not feasible due to the largevariation in patient internal and external anatomy. With this in mindthe presently described approaches, structures, and techniques encompassultrasound therapy alignment devices having customizable elements and/orthat are otherwise personalized for each patient's unique external bodyshape and size and to the patient's internal anatomy shape, size, andlocation. The systems and devices are customizable to address the largevariability in the overall patient population, while also being suitablefor use in non-clinical settings (e.g., home use by the patient).

By way of example, in certain embodiments discussed herein an alignmentdevice is provided as a wearable ultrasound therapy alignment device(e.g., a belt, a vest, and so forth) that includes configurable sizingor adjustment features, settings, optional swappable components, and/orsensors for personalization. Protocols are also provided for determiningthe personalized settings and for the fit of the alignment device toconfigure a given alignment device to a patient for a respective therapytarget (i.e., fitting protocols) and protocols are also described forthe use of a fitted alignment device in a therapy session administeredin a non-clinical setting, such as at the home (i.e., use protocols).After customization, the personalized sizing and/or alignment featuresenable repeatable positioning on the body of the respective patient andnominally aim and focus the ultrasound therapy beam at the internalanatomy target. Such a target region may be a portion or sub-portion ofa larger organ or structure, such as the porta-hepatis region within theliver or hilum region within the spleen.

To address the uniqueness of each patient's overall body shape and size,as well as the selected external location on the body, the wearablealignment device has customizable sizing, adjustable ultrasonic probeplacement, and features to secure the probe in place in a repeatablemanner and for hands-free operation. To address the uniqueness of eachpatient's internal anatomy, the alignment device may include angularadjustments (e.g., rock, tilt, spin) and configurable depth to nominallypoint and focus the therapy beam at the target region. Further, in someembodiments, after the location of the target is determined, the systemmay be configured to deliver therapy at that location by electronicallysteering the therapy beam to the determined location when applying atherapy dose. Alternatively, a therapy transducer having appropriatetherapy transducer characteristics (e.g., power handling, frequencyrange, geometry and so forth) and/or a probe cap having a suitable probecap characteristics (e.g., angular adjustment, attenuation adjustment(for example, standoff height and/or composition), other geometries orfeatures useful for focusing, shaping, or targeting the beam, and soforth) may be selected and employed to direct the therapy beam to thedetermined location when applying a therapy dose.

When determining the personalized settings as part of a fitting session,physical features that enable locking and unlocking the adjustments, anddigital features that enable storage of baseline target depth, targetlocation within the imaging plane, baseline image data for comparison,and other sensor readings may be employed. When in use in a non-clinicalsetting (e.g., the home), the patient or other user may be guided toposition the alignment device on the selected external location on thebody, secure (e.g., lock) the alignment device in place, and performfine adjustments to achieve the desired alignment. The alignment devicemay leverage prior information stored for the patient as well as onlinesensor data and a live ultrasound image, if available, to ensure properfit and probe placement.

In further examples, certain implementations discussed herein utilize analignment device or structure that is custom fabricated or molded to fita patient's external anatomy to ensure repeatable, accurate alignment toan internal ultrasound stimulation target region. Use of a customfabrication system may allow an untrained user in a non-clinical setting(e.g., a patient in their home) to safely conduct ultrasonic stimulationof a specific neural target region over multiple sessions without theneed for assistance from a sonographer or clinician. In particular, insuch implementations a custom fabrication process may be employed thatreproduces the initial placement accuracy of the therapy transducer.This, in turn, may allow therapy to be performed solely by the patient,such as in his or her own home. That is, such a custom fabricatedstructure can be used to repeatedly position the transducer in generallycorrect alignment with respect to a given patient, thereby allowing thepatient to self-administer ultrasonic neuromodulation to an internaltarget region. The degree of target alignment thereby provided isimproved relative to unguided positioning without the assistance of acustom fabricated fixture. In particular, the target alignment relativeto the neural target region is improved due to the customized nature ofthe alignment device, which may utilize patient-specific anatomicalfeatures to anchor the therapy transducer in the correct position andorientation.

With this in mind, FIG. 1 depicts an example of a neuromodulation systemconfigured to be used to deliver neuromodulating energy as part of atreatment protocol and which may be used with an alignment and/orpositioning device or structure as discussed herein. In particular, FIG.1 is a schematic representation of a system 10 for neuromodulation toachieve neuromodulating effects such as neurotransmitter release and/oractivation of components (e.g., the presynaptic cell, the postsynapticcell) of a synapse in response to an application of energy. The depictedsystem includes a pulse generator (as part of a therapy module 12)coupled to an energy application device (e.g., ultrasound transducer(s),such as depicted as part of the probe module 14). The energy applicationdevice is configured to receive, e.g., via leads or wireless connection,or otherwise generate energy pulses that in use are directed to a targetregion in an internal tissue or an organ of a subject, which in turnresults in a targeted physiological outcome.

In certain embodiments, the energy application device and/or the pulsegenerator may communicate wirelessly, for example with a controller thatmay in turn provide instructions to the pulse generator. As discussedherein, the energy application device may be an extracorporeal device,e.g., may operate to apply energy transdermally or in a noninvasivemanner from a position outside of a subject's body, and may, in certainembodiments, be integrated with the pulse generator and/or thecontroller. In embodiments in which the energy application device isextracorporeal, the energy application device may be operated by acaregiver, or the patient, and positioned at a spot on or above asubject's skin such that the energy pulses are delivered transdermallyto a desired internal tissue. Once positioned to apply energy pulses tothe desired site, the system 10 may initiate neuromodulation of one ormore nerve pathways to achieve a targeted physiological outcome orclinical effect. In some embodiments, the system 10 may be implementedsuch that some or all of the elements may communicate in a wired orwireless manner with one another.

The system 10 may include an assessment device or logic that assessescharacteristics that are indicative of the placement and orientation ofthe energy application device 14. Based on such an assessment, deliveryof therapeutic ultrasonic energy may be altered, modulated, or steeredautomatically to achieve the prescribed therapeutic result. By way ofexample, the therapy beam may be electronically steered to the targetlocation when applying a therapy dose. In addition or in thealternative, an indication or guidance may be provided to the user, suchas via audible, visible, or haptic indicators, to provide guidanceregarding placement and/or orientation of the energy application device12.

The system 10 as provided herein may provide energy pulses according tovarious modulation parameters as part of a treatment protocol to apply aprescribed amount of energy. For example, the modulation parameters mayinclude various stimulation time patterns, ranging from continuous tointermittent. With intermittent stimulation, energy is delivered for aperiod of time at a certain frequency during a signal-on time. Thesignal-on time is followed by a period of time with no energy delivery,referred to as signal-off time. The modulation parameters may alsoinclude frequency and duration of a stimulation application. Theapplication frequency may be continuous or delivered at various timeperiods, for example, within a day or week. Further, the treatmentprotocol may specify a time of day to apply energy or a time relative toeating or other activity. The treatment duration to cause the targetedphysiological outcomes may last for various time periods, including, butnot limited to, from a few minutes to several hours. In certainembodiments, treatment duration with a specified stimulation pattern maylast for one hour, repeated at, intervals, e.g., 72 hour intervals. Incertain embodiments, energy may be delivered at a higher frequency, sayevery three hours, for shorter durations, for example, 30 minutes. Theapplication of energy, in accordance with modulation parameters, such asthe treatment duration, frequency, and amplitude, may be adjustablycontrolled to achieve a desired result.

With the preceding context in mind, additional features illustrated inFIG. 1 are described in greater detail. In particular, aspects andcomponents of an implementation of the system 10 are shown as modulescorresponding to certain functionalities described above. As notedabove, the block diagram of FIG. 1 illustrates a therapy module 12 and aprobe module 14 which may be used to perform therapeutic functionsdescribed herein. An imaging module 16 is also illustrated, though itmay be appreciated that in certain embodiments such an imaging module 16may be absent. In such alternative embodiments analytics performed onimaging data may be performed on unreconstructed (i.e., raw) imagingdata or on image data that is reconstructed but not displayed. By way ofexample, therapy administration and/or control based on data acquiredusing imaging transducers or at the imaging module 16 may be based onreconstructed images (e.g., signatures within the reconstructed imagedata) or based on ultrasound signatures present in the unreconstructedimage data.

Beginning with the probe module 14, in the depicted example the probemodule 14 includes transducers 20. As used herein, a “transducer” refersto any arbitrarily sized and segmented physical structure for convertingto and/or from a first energy source (i.e. electrical, mechanical,magnetic, etc.) and ultrasonic energy, where the probe module 14includes a collection of one or more transducers. As discussed herein,the geometry of the collection of transducers could be a linear (1D)array, a 2D array, or any other suitable geometry of any size, while theimaging and therapy transducers as described herein could beindependent, partially shared, or fully shared. In some contexts, the“imaging transducer” or “therapy transducer” may be used to refer to thecollection of one or more transducers used for the associated imaging ortherapy function. In other contexts, an “imaging beam” or “therapy beam”may be discussed which is generated from a collection of one or moretransducers, wherein the collection of transducers used for generatingthe imaging and therapy beams may be independent, partially shared, orfully shared.

With this in mind, in the depicted example, the transducers 20 includeboth imaging transducers 22 and therapy transducers 24. In oneimplementation, the therapy transducer(s) 24 may operate at a frequencywithin 0.2 MHz to 2 MHz (such as 0.5 MHz or 2 MHz). The probe module 14and/or transducer(s) 20 may be selectable or swappable in certainimplementations to allow a clinician to choose an appropriate probemodule model or type to best fit the patient or target region context,such as by allowing the clinician to select the probe module 14 and/ortransducer(s) 20 having suitable nominal depth, axial focus locationcharacteristics, power handling, frequency range, angular adjustment,attenuation adjustment, and so forth. Further, in multi-transducerembodiments, a clinician may customize the probe module 14 by selectingthe subset of transducers for activation to enable coherent summation ofa therapy beam at a target region of anatomy with minimal interferenceby obstructing anatomic structures (e.g., ribs, and so forth).

In alternative embodiments, transducers 20 may instead comprise one typeof transducer capable of operating at both the respective imaging andtherapy frequencies (e.g., 0.2 MHz to 2 MHz during therapy operation and2 MHz to 12 MHz during imaging operation) such that separate transducersare not provided for each type of respective operation. In suchembodiments the single transducer or type of transducer may be operatedto both provide therapy and acquire imaging-type data. Such singletransducer type approaches may be suitable in contexts where the targetregion is shallow and/or high power is not necessitated. The probemodule 14 and/or transducer(s) 20 may be selectable or swappable incertain implementations to allow a clinician to choose an appropriateprobe module model or type to best fit the patient or target regioncontext, such as by allowing the clinician to select the probe module 14and/or transducer(s) 20 having suitable nominal depth, axial focuslocation characteristics, power handling, frequency range, angularadjustment, attenuation adjustment, and so forth.

In the depicted example the probe module 14 also includes a hardwarecontroller 30 which in the depicted example, includes amicrocontroller(s) (MCU) 32 in communication with a master controller(e.g., processor) 80 of the therapy module 12 and a field-programmablegate array (FPGA) 34 in communication with the MCU 32 and sensors 40and/or actuators 50 that may be present and associated with the probemodule 14. In this configuration the MCU 32 and FPGA 34 maybi-directionally communicate with components of the master controller 80to coordinate and/or record operation of aspects of the probe module 14or, if present, components associated directly or indirectly with theprobe module 14, such as actuators 50 and/or sensors 40. With respect tothe sensors 40, various types of sensors may be integrated with or, ifseparate, in communication with the probe module 14. By way of examplethe sensors 40 may include one or more of inertial measurement units(IMUs) (which may function as posture sensors), a contact force sensor,a tension or strain sensor, and so forth. As shown in FIG. 1, the one ormore sensors 40, if present, may be communicatively coupled to the FPGA34 or otherwise to the hardware controller 30.

Regarding the therapy module 12, as previously noted implementations ofthe therapy module 12 may include a master controller (e.g., processor)80 which may itself include or execute various sub-modules or routines,such as may be stored on a memory structure 84. For example, the mastercontroller 80 may include or execute modules or routines providingfunctionality for an image streamer and remote control, artificialintelligence (AI) anatomy recognition and tracking, a guided dosingengine, a user interface, support analytics, a data logger and so forth.

As with the probe module 14, in certain embodiments the therapy module12 may include a hardware controller 86 which may include its own MCU 88and FPGA 90. While depicted as separate modules for the purpose ofillustration and explanation, in practice the probe module 14 andtherapy module 12 may actually be one and the same (i.e., an integralstructure or device configured to perform the functions of both thetherapy module and probe module as discussed herein). With this in mind,though discussed separately herein, in practice the hardware controllers30 and 86 may be implemented as a single hardware controller. In thedepicted example the MCU 88 is depicted as being in communication withthe master controller 80 and its components and modules. The FPGA 90communicates with and/or controls other components of the therapy module12, such as therapy pulser-receivers 92 (depicted as being incommunication with the therapy transducers 24 of the probe module 14),safety circuitry 94, and/or power management circuitry 96. In practice,the master controller 80 in conjunction with the hardware controllers86, 30 may control operation of the therapy module 12 and probe module14, such as to perform application of therapy in accordance withprocesses and structures described herein. In addition, as shown in FIG.1, one or both of the master controller 80 and/or hardware controller 86may be in communication with one or more memory structures 84 (e.g., avolatile or non-volatile memory, a firmware construct, a mass datastorage, and so forth). As may be appreciated code or executableroutines for performing operations (e.g., therapy procedures orprotocols) may be stored on the memory 84 for use by other components.In addition, one or more configurable parameters (e.g., system settings,imager settings, sensor settings or thresholds, and so forth) may bestored in the memory structure 84, such as by a user who has configuredor calibrated the system 10 for use by a given patient for a respectivetherapy protocol. In addition, the memory structure 84 may be used tostore data (e.g., image data) acquired or generated as part of a therapyprocedure, such as for later readout and evaluation.

In the depicted example, an imaging module 16 is also depicted as beinga component of the overall system. Such a module, if present, maycontrol or monitor operation of transducers 20 (e.g., imagingtransducers 22) to control generation, collection, and/or processing(e.g., reconstruction) of imaging data. In the depicted example, theimaging module 16 is also shown as being in communication with themaster controller 80 of the therapy module 12, which may controloperation of or respond to feedback and data from the imaging module 16.As with the probe module 14 and therapy module 12 discussed above, theimaging module 16 is illustrated as a separate module in FIG. 1 tofacilitate illustration and explanation of the functional concepts.However, as with the preceding examples, the imaging module 16 mayactually be one and the same with one or both of the probe module 14 andtherapy module 12 (i.e., an integral structure or device configured toperform the combined functions of the imaging module and one or both ofthe therapy module and probe module as discussed herein).

With the preceding system description in mind and as context, thepresent techniques relate to an image (or unreconstructed image data)guided ultrasonic therapy system. In certain embodiments, a device orstructure to provide targeting and/or alignment assistance withoutmanual guidance is used in conjunction with the system 10 discussed withrespect to FIG. 1. Such targeting and alignment devices may includecustomizable elements and/or may be otherwise personalized for eachpatient's unique external body shape and size and to the patient'sinternal anatomy shape, size, and location. The systems and devices arecustomizable to address the large variability in the overall patientpopulation, while also being suitable for use in non-clinical settings(e.g., home use by the patient).

A variety of example embodiments of targeting and alignment devices,referred to herein collectively as probe positioning structures, aredescribed herein. These devices may, when used, facilitate theapplication of safe and effective ultrasound neuromodulation therapy,including in non-clinical settings and/or when operated by untrainedusers (e.g., the patient themselves or other individuals lackingclinical or medical training). As such certain of the presentlydescribed embodiments are designed or configured for ease of use by theend user.

By way of context, in conventional ultrasound scans there is ahigh-degree of variability across the patient population. A trainedsonographer adapts to such patient variability by adjusting the probeplacement location on the body, probe angles, and system settings toarrive at a diagnostic image of the target. As noted herein, the presentprobe positioning structures help avoid such manual operations (therebyfacilitating placement and use by an untrained individual) to allowpersonalized, easy, and repeatable probe positioning and hands-freeoperation during a therapy session.

With this in mind, in a first example of an implementation of a probepositioning device in the form of a wearable structure 100, as shown inFIG. 2, a body-worn, adjustable probe positioning structure is depictedthat is suitable for hands-free use (i.e., neither the device nor theaffixed probe need to be held during operation). In this example theprobe positioning structure may be provided as a wearable belt 106(shown), vest, harness, etc., although other wearable devices or rigs(suitable for the appropriate body location) may also be employed. Withthis in mind, the probe positioning structure in this embodiment maycomprise a body-worn, hands-free (i.e., the user does not hold eitherthe wearable structure 100 or the probe module in place using theirhands) fixture that is at least initially adjustable (i.e., on the firstuse or through a calibrating or fitting operation). In the depictedexample of a belt 106 the user may put on the belt 106 and adjust or fitthe belt 106, such as by adjusting one or more fitting features 112provided on the wearable structure 100 (e.g., tightening or looseningone or more straps or other adjustable features). Once worn and fittedin this manner, the belt 106 (or comparable wearable structure 100) maybe worn and used in a hands-free manner for the duration of a therapy ortreatment session.

The one or more fitting features 112 may include, but are not limitedto, tightening and/or cinching features like clips 114, locks,adjustable straps 116, ratchets, pull cords, lace tensioning systems, orinflatable features. Such tightening and/or loosening features may beeither manual (i.e., user operated or adjusted) or automated (e.g.,automatically adjusted utilizing a motorized mechanism in response tosensor and/or image data) as discussed herein. With respect to fit ofthe wearable structure 100, the wearable structure 100 may be providedin multiple sizes (e.g., small, medium, large, extra-large) and theclosest size selected for a patient prior to adjustment. Alternatively,the wearable structure 100 may be provided in a single size (i.e., onesize fits all) and the fitting features 112 relied upon solely to adjustor adapt the fit of the probe positioning structure to each patient.

In FIG. 2, a probe 14 (e.g., a central dual-mode imaging/therapyultrasound probe) is illustrated as attached to a coupling structure orfeature 140 (e.g., a probe clip or connector) of the wearable structure100. It may be noted that other probe configurations (e.g., non-centraland/or multi-transducer configurations) connected to or positioned onthe wearable structure 100 are also possible.

One or both of the wearable structure 100 or the probe 14 may includesensors that may be used to measure and guide fitting of the wearablestructure 100. By way of example, the probe 14 and/or wearable structure100 may include an inertial measurement unit (IMU) 150 as a posturesensor. Such an IMU 150 may be embedded within the probe 14 and may beemployed in a fitting session to measure device (e.g., probe)orientation (which may correspond to a patient posture) that is suitablefor a treatment or therapy session. Measurements from the IMU 150 maythen be used in a dosing or treatment session to ensure the posture ofthe patient corresponds to what is anticipated based on the fittingsession. By way of further example, a contact force sensor 152 may alsobe provided, such as on a patient-facing surface of the probe 14. Insuch an example, the contact force sensor 152 may be used in a fittingsession to measure contact force between the probe 14 and patient,thereby obtaining a measurement or guidance for adjustment in theZ-dimension in the direction running from the probe face into (i.e.,toward) the patient. Measurements from the contact force sensor 152 maythen be used in a dosing or treatment session to ensure proper contactforce is present before the dose is applied. By way of an additionalexample, a tension or strain sensor 156 may also be provided, such as ata connection point on the belt 106. In such an example, the tensionsensor 156 may be used in a fitting session to measure tension baselinebelt tension when the belt 106 (or other wearable structure 100) isproperly fitted to the patient. Measurements from the tension sensor 156may then be used in a dosing or treatment session to ensure propertensioning before the dose is applied.

Turning to FIG. 3, a further example of a wearable structure 100 in theform of a belt 106 is provided for the purpose of illustrating acontemplated manual adjustment mechanism in x-, and y-dimensions (i.e.,along the surface of the patient in vertical and horizontal directions,as opposed to toward the patient in the z-dimension). In this example,the belt 106 may be fitted to the patient using a mechanism as describedwith respect to FIG. 1. A probe 14 having patient-facing transducer(s)20 is provided on the belt 106 either as an integral feature of the belt106 or a mountable (e.g., clippable) attachment. For example, as notedherein, the probe 14 (may be a central dual-mode imaging/therapyultrasound probe) and may attach to a coupling feature (e.g., a probeclip or connector) of the wearable structure 100, here belt 106. In FIG.3, the belt 106 is shown from a perspective view in which thepatient-facing surface of the probe 14 is visible through an acousticwindow 180 provided in the belt 106.

In one implementation utilizing the wearable structure 100 as shown inFIG. 3, the belt 106 may be applied to the patient and the probe 14, andassociated transducer(s) 20 can be moved in the x-, y-dimensionsrelative to the acoustic window 180 of the belt 106 to achieve placementof the probe 14. In certain such embodiments, the user may adjust theposition of the transducer(s) 20 by moving the probe 14 in the x- andy-dimensions relative to the acoustic window 180 while the system 10analyzes concurrently acquired ultrasound image data. In one embodiment,the system 10 guides the user (e.g., using optical, audible, and/orhaptic feedback or cues) to move the probe 14 in the x- and y-dimensionsrelative to the acoustic window 180 to obtain alignment with the targetregion. Alternatively, in another implementation the user randomly movesthe probe 14, and associated transducer(s) 20 within the acoustic window180 until the system 10 indicates that alignment with the target regionhas been achieved. The indication may be a binary yes/no, or the system10 may guide during the random motion using optical, auditory, and/orhaptic cues or feedback (e.g., by beeping faster or louder (or similarvisual feedback) as the user gets closer to the aligned position).

As in the example discussed with respect to FIG. 2, the belt 106 of FIG.3 may also be fitted with sensors 40 that may be used to measure andguide fitting of the belt 106. By way of example, sensors 40 may beemployed to measure and/or provide feedback with respect to belttightness, contact force, posture, and/or body position.

In further embodiments the belt 106 may not allow or may limitadjustment of the transducer(s) 20 in the x-, y-dimensions subsequent tothe belt 106 being fixed in place. In such embodiments, the x-,y-alignment of the transducer(s) 20 may be done prior to locking down(i.e., securing) the belt 106 for a therapy session. For example, theuser (e.g., patient) may place the belt 106 (or other positioningdevice) in the appropriate general position on the patient (e.g.,without tightening or locking the belt 106 in position). The user maythen shift or adjust the placement of the probe 14 or the wearablestructure 100 (e.g., belt 106) with the probe 14 attached untilalignment with the target region is achieved, such as via a feedback ornotification mechanism as described above. Once alignment with thetarget region is obtained, the user (e.g., patient) may tighten orsecure the wearable structure 100 to lock the probe 14 into position forthe therapy session.

In another implementation, the wearable structure 100, such as the belt106, may include a locking mechanism (e.g., a quick locking mechanism)that the clinician may utilize during a fitting session to lock or fixthe position and orientation of the probe 14 once the proper positionand orientation are determined and once the probe is re-engaged orattached to the belt 106. In such an embodiment, the locking mechanismprevents or limits, once locked, manipulation or adjustment of the probeposition and orientation settings specified by the clinician, even whenthe probe 14 has been disengaged or removed (e.g., unclipped) from theprobe positioning structure 100, such as when not in use. In thismanner, a non-clinician user may be prevented or limited in theirability to reposition or reorient the probe 14 when attached to thewearable structure 100 after the fitting process.

In one such example, during an initial fitting or calibration session aclinician manually adjusts the fit of the belt 106 and the probe 14coupled to the belt 106 relative to the acoustic window 180 to align thetransducer(s) 20 of the probe 14 with the target region. During fitting,the clinician may also adjust the fit of the probe 14 in the z-dimensionfor optimal probe placement with respect to the target region and toensure good acoustic contact with the patient when fit. The fittingsession may also fix the orientation of the probe 14 (as opposed to thex-, y-, and z-dimension positioning of the probe) when affixed to thebelt 106, such as by adjusting one or more of roll, pitch, or yaw (e.g.,rock, tilt, spin, and so forth) of the probe 14 when affixed to the belt106 so as to be calibrated or locked to a suitable (e.g., optimal) scanplane with respect to the target region. Once the position andorientation of the probe 14 are so determined such as to align with thetarget region, the locking mechanism may be set or locked so that theprobe 14, when coupled to the wearable structure 100 is aligned with thetarget region when the wearable structure 100 is applied to the patientand secured.

In this manner, once the wearable structure 100 and probe 14 are fittedfor subsequent therapy sessions, the user (e.g., patient) may apply thewearable structure 100 and probe 14 during a therapy session such thatthe probe 14 is properly positioned and oriented to apply therapy. Incertain embodiments, the user may be allowed a limited ability adjustthe position of the transducer(s) 20 by moving the probe 14 in the x-,y-, and/or z-dimensions relative to the acoustic window 180 to a limitedextent while the system 10 analyzes concurrently acquired ultrasoundimage data. That is, in some implementations the range over which theuser may make adjustments to the position and/or orientation of theaffixed probe 14 may be limited in scope if a lockout mechanism isemployed, essentially allowing a user the ability to fine tune oroptimize the position and orientation of the probe 14 within the limitsset by the locking mechanism. In one embodiment, the system 10 guidesthe user (e.g., using optical, audible, and/or haptic feedback or cues)to move the probe 14 in the x- and y-dimensions relative to the acousticwindow 180 to obtain final alignment with the target region.

While the preceding discussion relates various aspects of a generalizedprobe placement device design and associated fitting concepts, variousillustrative design and use examples will be provided below toillustrate real-world or practical implementations or aspects of suchapproaches. By way of example, and turning to FIGS. 4 (an external view)and 5 (a corresponding cut-away view), an example of one implementationof a probe holder 200 suitable for coupling to a wearable structure 100(such as at acoustic window 180 and using coupling features 140) isillustrated. The depicted example of a probe holder 200 may allow formanual adjustments (such as by a clinician performing an initial fittingor calibration or by a non-clinical user) with respect to the x- andy-dimensions (i.e., the x- and y-positioning within the acoustic window180 of a wearable structure 100 and/or placement of the wearablestructure 100 itself) as well as with respect to the z-dimensionorthogonal to the patient skin surface and/or the angle or tilt of theprobe 14 (i.e., angular adjustment). In addition, the exampleimplementation depicted provides a locking mechanism to lock both thez-axis positioning, angular positioning, and so forth once fitted to thepatient.

The probe carriage frame 208 is connected to a z-axis rail 210 via az-axis carriage 212 so as to allow the probe module 14, when attached tothe probe carriage frame 208 to be moved in the z-dimension (i.e.,toward or away from the patient). As shown more clearly in the cut-awayview of FIG. 5, a spherical joint 220 is also provided which residespartially within an indent of the z-axis carriage 212 and connects tothe probe carriage frame 208. In this example, the spherical joint 220allows the probe carriage frame 208 (and attached probe module 14) torock, tilt, and/or spin based on the range of motion provided by thespherical joint 220.

A spherical joint clamp 222 is provided that secures the spherical joint220 with respect to the z-axis carriage. In the depicted example, thespherical joint clamp 222 is connected to a clamp lever 226 that may bemanually actuated between a locked and unlocked position. In thedepicted example, the clamp lever 226 is illustrated along the side ofthe z-axis rail 210 and is coupled to an extension that passes throughthe z-axis rail 210 and z-axis carriage 212 to engage with the sphericaljoint clamp 222. By moving the clamp lever 226 from the unlocked tolocked position, a user may simultaneously lock movement of the z-axiscarriage 212 and the spherical joint 220 so as to lock the probecarriage frame in the z-dimension and in the spin, rock, and tiltorientations.

With respect to focus in the z-dimension, while the movement andsecuring of the probe module 14 in the z-dimension is one approach toachieving the proper focal plane, it should also be appreciated thatselection of a suitable probe module 14 from among a set of availableprobe modules may also be part of achieving suitable z-focus. By way ofexample, a set of available probe modules having suitable therapytransducers (e.g., single element transducers) may each have a differentrespective intrinsic z-dimension focus (e.g., 6 cm, 8 cm, 10 cm, and soforth), as represented by therapy beam cone 206. At a fitting session aclinician may select a probe module 14 from the set of available probemodules that best matches the depth of the target region for therespective patient. The selected probe module having an intrinsicz-focus may be paired with the probe holder 200 for fitting and/orcalibration.

In addition, the respective probe modules 14 from the available set mayalso (or instead) differ with respect to the angle or orientation of theprobe module 14 with respect to the patient. As shown in FIG. 6, theangular orientation of the respective probe modules 14 with respect tothe patient (i.e., to direct the focal beam to the correct x-positioncorresponding to the target region within the focal plane) may bedetermined by a probe cap 204 with which the probe modules 14 areaffixed. Such probe caps 204 may be permanently affixed to the probemodules 14 or may be removable and interchangeable. Different probe caps204 may be associated with a different respective angular orientation(e.g., −20°, −10°, 0°, 10°, 20°, and so forth) such that selection of aprobe cap 204 determines the angular orientation of the probe module 14with respect to the patient once affixed to the probe holder 200. By wayof example, a swappable probe cap may adapt the angle at which the probemodule 14 contacts the body surface so as to reduce the rock or tiltangles on the body surface or size of the acoustic aperture to best fitthe access zone and anatomical target for the patient. In addition to orin the alternative of this angular adjustment, probe caps 204 may alsobe distinguished by and selected based on attenuation characteristics oradjustment (e.g., standoff height, standoff composition, and so forth),geometry and/or focusing features useful for focusing, shaping orotherwise targeting the beam), and so forth.

Turning back to FIGS. 4 and 5, the probe holder 200 includes a frame 250which functions as an attachment interface to a belt, vest, or otherpositioning structure so as to form the probe positioning aggregatestructure. In this example, the z-axis rail 210 attaches to the frame250 (such as via rail mount points) so as to attach the componentsconnected to the z-axis rail 210 (e.g., the remainder of the probeholder 200) to the frame 250. In this example, the frame 250 includesattachment points 254 (e.g., belt rail mount points) that may engagewith a complementary structure (e.g., an anchor point or attachmentrail) on a positioning device, such as a belt. For example, theattachment points 254 on the frame 250 may engage or secure tocomplementary attachment points on an attachment rail provided on a beltor vest of a probe positioning structure.

With the preceding discussion in mind of a probe holder 200 that may besuitable for incorporation with a wearable structure 100, as generallydiscussed within, the following three examples illustrate differentapproaches for implementing a probe positioning structure. It should beappreciated that the following examples are merely illustrative ofdifferent concepts and are not intended to limit the manner in which aprobe positioning structure may be provided. Instead, the followingexample are merely intended to provide context and a real-worldframework to better illustrate and explain how such a probe positioningstructure might be implemented and employed. As may be appreciated, tothe extent that the various wearable structure 100 implementationsdiscussed herein are of a suitable size and/or flexibility, such probepositioning structures may be configured to fit in or be otherwisestored in a compartment in a therapy module 12 for use with the probemodule 14. In this manner, the wearable structure 100 may beconveniently stored with the devices with which it is to be used.

Turning to FIGS. 7 and 8, a wearable structure 100 in the form of a belt106 is illustrated that has one or more tensioning features and which iseasy to put on and remove. In one embodiment, the belt 106 may be a “onesize fits all” belt that is customizable or configurable to fitdifferent body sizes or weights. For example, the implementation shownin FIG. 7, and with certain fitting and/or adjustment featureshighlighted in FIGS. 8 and 9, may be initially configured or fit in afitting session and later applied by a clinician or by a non-clinicianfor therapy sessions. As may be appreciated, in practice the belt 106may be oriented or positioned to hold the probe module 14 in aclinically relevant position and orientation and thus the probe module14 may be held on the front, back or side of the patient. In certainembodiments, for ease of use by a non-clinician, the probe module 14 mayinclude a power on/off button or switch 246 of an outward facing surfacefor easy activation.

By way of example, the belt 106 may be secured and released via amagnetic closure 256 that is easy and quick to operate. Adjustments maybe accomplished using a pull-string lace tightening system, which isillustrated in FIGS. 7 and 8 and including a pull string 240 having apull handle 242 and which controls the separation provided by one ormore lace or webbing portions 244 of the belt 106, thereby allowingtightening or loosening of the belt 106. By way of example, during afitting session, the belt 106 may be secured, such as via magneticclosure 256, and once secured, the pull handle 242 tightened to causethe belt 106 to fit the patient in a manner that placed the probe module14 in the appropriate location and orientation. The pull string 240 andpull handle 242 may then be secured by cable or cord fastening features252 so as to prevent adjustment to the fit. The cable fastening features252 may also be used to secure other cables or strings, such as a probemodule cable 260 running between a therapy module and the probe module14.

In certain embodiments, the probe module 14 may be configured tocommunicate with the therapy module or a consumer electronic device(e.g., an application running on a cellular telephone of the patient) tofacilitate electronic troubleshooting or alignment. By way of example,once the fitted belt 106 and probe module 14 are applied to the patient,the patient may utilize an application on a cellular telephone toperform an automatic adjust or alignment process that may electronicallyalign and steer the therapy beam so as to address small misalignments.

Aspects of this adjustable system are illustrated in FIG. 8, along withother aspects that may facilitate adjustment and/or fitting to apatient. For example, in FIG. 8 the pull handle 242 and pull string 240are shown in an operable configuration such that pulling the pull handle242 will tighten the webbing portion 244. In addition, the belt 106 isshown as being trimmable to remove excess length 270, such as during afitting operation. For example, in an implementation where the belt 106is “one size fits all”, the belt, 106, when fitted, may include anexcess length 270 that can be cut and removed by the clinicianperforming the fitting operation. A clip 272 be secured to the belt tosecure the end and cover the cut edge, if present.

Turning to FIG. 9, in a further refinement, the probe module 14 mayinclude non-slip protrusions (e.g., bumps, bumpers, “feet”) on thepatient facing surface so as to limit or eliminate sliding once theprobe module 14 is positioned against the patient. By way of example,the protrusions may press into the patient to suppress movement of theprobe module 14 when the fitted belt 106 is applied to the patient.

Turning to FIGS. 10 and 11, an example of a wearable structure 100 inthe form of a belt 106 is illustrated that employs automated tensioning.As in the preceding example, the belt 106 may be a “one size fits all”belt that may fit different body sizes or may come in a limited numberof adjustable sizes that can be fit to different body sizes (e.g., one,two, or three sizes). An automated tensioning process, as discussed ingreater detail below, may be employed to fit the belt 106 to the patientonce applied. As may be appreciated, in practice the belt 106 may beoriented or positioned to hold the probe module 14 in a clinicallyrelevant position and orientation and thus the probe module 14 may beheld on the front, back or side of the patient.

In the depicted example, the belt 106 may be applied or fitted to thepatient using hook-and-loop fastening system 280 along one side, thoughother fastening mechanisms may also be employed as appropriate. Onceapplied to the patient, an automated process may be employed to operatean inflatable cinching system integrated with the belt 106 to apre-defined tension against the patient. The pre-defined tension may beconfigured or set by a clinician as part of an initial fitting processand/or may otherwise pre-defined based on standardized tensionparameters. As part of the tensioning process, one or more sensors(e.g., a contact force sensor, a tension or strain sensor) provided inone or both of the probe module 14 or wearable structure 100 (e.g., belt106) may be used to provide strain or force measurements to aprocessor-based device executing the automated tensioning process. Byway of example, the processor-based device may be the therapy module 12,the probe module 14, or a separate device, such as a computer, tablet,or cellular telephone 290, as shown in FIG. 11 and discussed below.

Turning to FIG. 11, internal structural components 292, such as springsteel components (shown by shading) of the belt 106 may be provided thatmaintain a rounded (e.g., circular or oval) shape to the belt 106 andwhich may facilitate putting the belt 106 on and taking it off. Forexample, such structural components 292 help maintain the shape of thebelt 106 and may be easily separated to apply or remove the belt 106.

In addition, the belt 106 may include air bladders or other inflatableportions that may be inflated to varying degrees to achieve a prescribedor defined fit to the patient (based on contact force or tension). Forexample, as noted above, one or more sensors (e.g., a contact forcesensor, a tension or strain sensor) provided in one or both of the probemodule 14 or wearable structure 100 (e.g., belt 106) may be used toprovide strain or force measurements in a real-time manner to anexecutable tensioning routine controlling inflation of the inflatableportions such that the tensioning routine continues to inflate theinflatable portions until a prescribe tension or contact force isreached. Once the prescribe tension or contact force is reached, theprobe module 14 may be further aligned electronically (if necessary) andtherapy administered.

In the depicted example, a processor-based device in the form of acellular telephone 290 is illustrated which may implement or otherwisecontrol operation of the tensioning routine and of the probe module 14and/or therapy module 12. For example, the cellular telephone 290 maystore and execute an application that may start and control inflation ofthe belt 106 and/or start the therapy session once inflation iscompleted. In addition, between the steps of inflating the belt 106 andapplying the therapy, processes executing on the cellular telephone 290(or otherwise controlled by cellular telephone 290) may perform anautomatic adjust or alignment process that may electronically align andsteer the therapy beam so as to address small misalignments.

Turning to FIGS. 12, 13, and 14, an example of a wearable structure 100in the form of a vest 300 is illustrated that provides greater patientcoverage and/or greater control of probe position. The vest 300 may beprovided in multiple sizes (e.g., XS, S, M, L, XL) that fit differentbody sizes or types. As may be appreciated, in practice the vest 300 maybe oriented or positioned to hold the probe module 14 in a clinicallyrelevant position and orientation and thus the probe module 14 may beheld on the front, back or side of the patient.

In the depicted example, the wearable structure 100 in the form of avest 300 includes one or more tensioning features to facilitate fittingof a given vest 300 to a respective patient. For example, theimplementation shown in FIG. 12 may be initially configured or fit in afitting session and later applied by a clinician or by a non-clinicianfor therapy sessions.

By way of example, the vest 300 may be secured and released via amagnetic closure that is easy and quick to operate. In the alternativeor in addition, one or more zippers 306 may be provided for securing thevest 300 when applied. Adjustments, in one implementation, may beaccomplished using a pull-string tightening system, which is illustratedin FIG. 12 as including a pull string or strap 240 having a pull handle242 and which controls the separation provided by one or more lace orwebbing portions of the vest 300. By way of example, tightening of thepull string or strap 240 via the pull handle 242 may tighten a pullwebbing portion of the vest 300 about the abdomen and/or shoulders of apatient and may be utilized to tighten (or loosen) portions of the vest300.

In the depicted example, (and as shown in FIG. 14), the probe module 14fits within a pocket 310 or other holder to be in contact with thepatient's skin 304. The pocket 310 may be provided or formed integrallywith the vest 300. By way of example, the pocket 310 may include abracket or other structural feature with which the probe module 14engages when inserted into the pocket 310. The pocket 310 may beconstructed so as to ensure tension between the probe module 14 (wheninserted) and the patient (i.e., when the probe module 14 is insertedinto the fitted vest, the probe module 14 pushed into the body of thepatient). When in the pocket 310, a cord 260 associated with the probemodule may be routed through the vest 300 (e.g., through layers orpassages formed within the vest 300.

Turning to FIG. 13, a sequential series of illustrations are providedillustrating an example, of a patient donning a vest 300 and inserting aprobe module 14 into an integral pocket 310. As shown in this example,the patient initially dons the vest 300 over his head (upper left). Thesides of the vest 300 are then secured, such as via magnetic closuresand a zipper 306 is used to secure the vest 300 in a vertical direction(i.e., top to bottom) (upper right). Pull strings 240 may be pulled totighten the vest 300 about the abdomen and/or shoulders of the patient(lower left). A probe module 14 may then be secured with a pocket 310 ofthe vest (lower right).

In certain embodiments, and turning back to FIG. 12, the probe module 14may be configured to communicate with a processor-based device (e.g., acellular telephone 290) which may implement or otherwise controloperation of the probe module 14 and/or therapy module 12. For example,the cellular telephone 290 may store and execute an application that mayfacilitate electronic troubleshooting or alignment. By way of example,once the fitted vest 300 and probe module 14 are applied to the patient,the patient may utilize an application on a cellular telephone toperform an automatic adjust or alignment process that may electronicallyalign and steer the therapy beam so as to address small misalignments.

Certain of the preceding implementations reference a fitting operationor session for adjusting a probe positioning structure as discussedherein. Such a fitting session may be employed for a first-time setup ofa probe positioning structure for a respective patient and therapyprotocol. In such a fitting session, patient-specific physicaladjustments to the wearable structure 100, imaging parameters, andaccess location are all determined and recorded, such that the wearablestructure 100 may be reconfigured at any time for that patient. Incontrast to the fitting session, a dosing session is the normal mode ofoperation (i.e., application of a treatment), where the patient oranother non-clinician operates the fitted wearable structure 100, suchas on their own in their home. In an example of one such dosing session,the patient puts on the fitted wearable structure 100 (e.g.,personalized body-worn device) while receiving system guidance and untilalignment of the ultrasound image to the target is found. The systemthen operates in a hands-free autonomous manner until the treatment doseis complete.

Turning to FIG. 15, an example of steps performed in a fitting sessionis illustrated in the form of a process flow. It should be appreciatedthat the described steps and their sequence is merely provided forillustration and, in practice, certain actions may be performed in adifferent sequence or in parallel to one another. Indeed, the describedsteps and their order are merely provided for the purpose ofillustration and to provide one example of a real-world context andimplementation, and should not be viewed as limiting.

Turning to FIG. 15, in implementations where a wearable structure 100comes in more than one stock size or type, a clinician may initiallyselect (step 350) the size (e.g., small, medium, large) or type (belt,vest) of the wearable structure 100 to be fitted to the patient. A basicfitting step may then be performed (step 354) for the patient using theselected wearable structure 100. By way of example, the clinician maysecure the wearable structure 100 to the patient (e.g., strap thebody-worn device onto the patient) and may adjust one or more featuresof the device to obtain a basic fit. The probe module 14 may then beapplied (step 358) and an initial probe adjustment performed (step 362).By way of example, the initial probe adjustment may include, but is notlimited to, the clinician maneuvering the probe module 14 in six degreesof freedom (x-, y-, and z-position, rock, tilt, and spin (e.g., roll,pitch, and yaw)) while the patient breathes normally in order to locatethe target region and to position the access point or window (i.e., thex-, y-position) on the body of the patient. As part of this process, theclinician may select or swap components of the probe module 14 (such asthe selected transducers 20 and/or probe cap 204) or the probe module 14itself in order to obtain the best alignment, depth, power delivery,angular extent, and so forth with the target region within theconstraints of the overall system. By way of example, at this stage aclinician may select an appropriate probe SKU (stock-keeping unit for aunique configuration) or part to best fit the determined configuration.Examples of this approach may include selecting a swappable therapytransducer that adjusts the nominal depth, frequency, power delivery,and/or axial focus location and/or a swappable probe cap that angles theprobe module 14 to reduce the required rock or tilt angles on the bodysurface, attenuates or shapes the therapy beam, or fits the size of theacoustic aperture to best fit the access zone and anatomical target forthe patient.

Once these initial steps are done, a tensioning step may be performed(step 370). During this step the clinician may tension the wearablestructure 100 (e.g., belt or vest) to lock the access point (x-,y-position) into position. A final probe positioning step may beperformed (step 374) after tensioning. During this step the clinicianmay perform fine adjustments in four degrees of freedom (z-position,rock, tilt, and spin) to find the optimal probe position for a therapysession. Such optimal probe position will typically be based on thetarget alignment being acceptable for a sufficient percentage (e.g., 60%70%, 80%, and so forth) of the respiratory cycle. Such target alignmentoptimization may be based on, but is not limited to, the target beingmaintained in the center of the field of view, the target being withinthe imaging plane, the target being within the electronic steeringcapability of the probe module 14, and so forth.

Once final probe positioning is performed, the clinician may lock theprobe module 14 in position (step 378). The clinician may then releasethe probe module 14 and confirm the stability (step 382) of the fit ofthe probe module 14 on the body. These steps may be iterated andrepeated until the observed stability is determined to be satisfactory.

The clinician may optimize the imager settings (step 386) once the probepositioning has been finalized. By way of example, the clinician mayoptimize the imager settings to obtain the best image quality inimplementations in which imaging is performed in support of, or as partof, therapy administration. The image settings, as described below maybe stored for use going forward with the patient. Examples of theultrasound image settings include, but are not limited to depth, gain,frequency, and other common parameters to maximize image quality.

Once the position and imager settings are established as set forthabove, one or more test runs may be performed (step 390) with thepatient. By way of example, the patient may be taught how to put on thewearable structure 100 and may be observed performing some number oftrials (e.g., 1, 2, 3, 4, 5, and so forth) to test the repeatability ofthe fit. As part of the patient trial process, the clinician may repeatone or more of the earlier steps to provide a secure and repeatable fitof the wearable structure 100. Once the wearable structure 100 and probemodule 14 are fitted and configured, system settings for the embeddedimager and computing electronics are determined and stored for use goingforward. By way of example, settings may be recorded and stored (step394) for the physical adjustments 398 of the wearable structure 100. Inaddition, the clinician or system may record and store imager setting402 and/or sensor readings 406 related to the fit of the structure 100(e.g., contact force or tension, posture, and so forth). Such image andor sensor fit settings (e.g., sensor outputs) may be used in subsequentsessions to check and guide the fit of the wearable structure 100 in anon-clinical therapy context. Similarly, the location (depth and axialposition) of the target within the optimal scan plane may be determinedand stored for subsequent uses. The stored settings may be employed toguide a user at home (or in another non-clinical setting) to checkproper fit of the wearable structure 100 when used in the non-clinicalsetting.

While the preceding relates to example steps in fitting a probepositioning structure, it should be appreciated that additional stepsmay be taken as part of a fitting session. For example, as part of sucha session, patient-specific baseline imaging data may be acquired forautomated processing. Similarly, mock dosing sequences may be performedto test performance.

It may also be noted that probe module 14 and or probe holder 200 designand/or selection may be an aspect of the fitting or design process. Inparticular, probe modules 14, probe holders 200, and specificcombinations of probes and holders may vary in their range of motionextents when fitted and attached to the wearable structure 100. Inparticular, when a probe module 14 is moved as part of a fittingprocess, motion of one type may be limited by or dependent on otheraspects of the probe's orientation. For example, the maximum “rock”orientation of a probe may be dependent on the tilt angle and/or spinangle of the probe. This dependency is a function of the design of theprobe module 14 and of the probe holder 200 (e.g., of a ball capturemechanism of the holder with respect to the wearable structure 100).

With this in mind, probe modules 14, probe holders 200, and specificcombinations of probes and holders may be designed to have specific orknown characteristics with respect their motion dependencies andinterrelationships. In this manner, a suitable probe module 14 and probeholder 200 may be selected in the fitting process.

With respect to the design and/or characterization of probe modules 14and probe holders 200 in terms of their motion characteristics, certaintechniques may be employed and are hereby described for completeness. Inone such characterization technique, different combinations of probemodules 14 and probe holders 200 are optically tracked for relativeorientation (for each frame acquired) with respect to a wearablestructure 100 while moved through a full range of motion for differentpermutations of orientation. In one example, the relative orientation iscomputed for the probe and wearable structure (e.g., belt) using inversekinematics and known models of the components in question.

To determine the range of motion extents a convex hull (i.e., a convexthree-dimensional (3D) structure) of a Delaunay triangulation can thenbe created based on orientation range-of-motion values displayed in 3space, where x-values=rock, y-values=tilt, and z-values=spin, the threeangles describing the spherical joint. In practice, the convex hull maybe an envelope generated using a 3-space point cloud derived fromobserved tracking data transformed to relative angular joint data whilemoving the tracked probe module 14 (fitted within a tracked probe holder200) relative to the wearable structure 100. This triangulation surfacefor a given probe module 14 and probe holder 200 represents the extentsof the range of motion as a convex surface. In this manner, for a givenvalue in one orientation (e.g., a given “tilt”) the extent of motionavailable for the other angles (e.g., “rock” and “spin”) for a givenprobe module 14 and probe holder 200 may be determined. A similarapproach could be used to determine the range-of-motion andconfiguration dependent limitations for a given probe and probe holderwith a non-spherical joint or joints (i.e., prismatic and/or revolute).Alternatively, the convex hull may be generated from simulated relativemotion of CAD models during the design process.

In practice, the outer boundary of the convex hull is of primaryinterest as it represents the extent of motion. That is, in thiscontext, the boundary of the convex hull represents theconfiguration-dependent extends of the rock, tilt, and spin angleparameters for a given probe and probe holder combination, therebydefining the configuration-dependent range of motion envelope for thethree orientation angles.

To simplify interpretation of the 3D structure corresponding to theconvex hull, two-dimensional “slices” may be generated through the 3Dstructure along an axis so as to better view the range of motion for theother two orientation angles at a given point on the axis (e.g.,“slicing” the 3D structure with the z=0, x-y plane.) This corresponds,conceptually, to holding one angle fixed while moving the other twoangles and finding, within a plane, the limits of those angles for thefixed first angle (e.g., how much can one vary the rock angle and tiltangle for a fixed spin angle).

This is illustrated in FIG. 16 as a series of isoangle contours 410,with each contour corresponding to a different position in thez-dimension (here the spin dimension) for a different probe/probe holderrange of motion relative to a given patient (or wearable structure 100in certain contexts). The edges of each isoangle contour 410 in thisexample show the range of motion for tilt (vertical axis) and rock(horizontal axis) for different probe/probe holder combinations atdifferent values of constant spin (the different subplots). Using suchtechniques, different probe modules 14, probe holders 200, and/orcombinations of probes and holders may be evaluated for suitability in afitting operation as discussed herein. In the example illustrated inFIG. 16, two different combinations of probes and holders, 410 a(H2run1, H2run2, and H2run3) and 410 b (H2wTilt), are evaluated forsuitability of fit for 7 different patients (collectively patients 412(G7, T0, H8, Q4, X7, D2, W2)). Both probes and holders, 410 a and 410 b,can accommodate all 7 patients but probe and holder 410 b may beundesirable since it leaves little margin for rock and tilt adjustmentat the configured spin angle for patient X7. Herein, probe and holder410 a provides a more suitable fit for all of the 7 different patients.Similarly, a probe module 14 and/or probe holder 200 may be designed toprovide a desired range of motion utilizing these techniques forevaluating range of motion or, alternatively, existing designs may becompared in terms of their range of motion.

The preceding discussion relates examples in which the wearablestructure 100 or an aspect of the wearable structure 100 is aconfigurable garment or item that may be adjusted via various fittingstructures or techniques (e.g., pull straps used to tighten webbing,adjustable or trimmable straps, inflatable air bladders, and so forth).In other embodiments, the wearable structure 100 (or component(s) to beused in conjunction with probe positioning structure, such as acustomized transducer placement fixture or plate), may instead bemanufactured or otherwise constructed based on the individual patient'sbody. That is, instead of being an adjustable “one size fits all” deviceor garment or having discrete size bins of customizable devices orgarments, each individual wearable structure 100 or component(s) used inconjunction with probe positioning structure may be constructed based onthe body of the patient so as to be unique to that patient. Thus, insuch an implementation, the fitting process or session may instead beperformed to parameterize and construct a custom-fitted wearablestructure 100 or component specific to the patient, such as acustom-fitted probe interface device, as opposed to adjusting a moregeneral wearable structure 100 or component to fit the patient.

By way of example, and turning to FIG. 17, in one implementation, apatient may be digitally scanned (step 420) for surface profilometry 422using an infrared depth sensor, laser scanning technology, or otheranthropometric means. The surface profile scan may be conducted in aclinical setting (e.g., in the clinician's office) or in a non-clinicalsetting (e.g., at the patient's home using a portable system andtraveling operator or performed by the patient themselves, such as usinga cellular telephone application that uses profile scanning technology).Such a scan may, in one embodiment, take less than one minute (e.g., 30seconds) and may provide certain advantages, such as being able to beperformed without patient contact and while the patient remains clothed(e.g., form-fitting clothing) thus allowing patient privacy.

The digital surface profile scan data (e.g., surface profilometry 422),however obtained, may be used to fabricate a custom-fitted fixture 426(e.g., an ultrasound probe interface device) used to hold and position aprobe module 14 relative to the patient during a treatment session. Thecustom-fitted fixture 426 may include, but is not limited to, atransducer mounting plate affixed to or integral with a customfabricated component that conforms to the patient anatomy. With respectto fabrication of such a custom-fitted fixture 426 based on the surfaceprofile scan data 422, such a fixture may be additively manufactured(e.g., 3D printed) or otherwise manufactured (step 424) using a suitablecustom manufacture technique. For example, with respect to a transducermounting plate being incorporated with a custom-fitted fixture 426,since only one custom plate is needed, a 3D printing approach may besuitable. In such an implementation, the patient-facing side of thefixture may have a geometry determined by the surface profilometry 422while the opposite face or surface (i.e., the exposed side) may have acommon transducer mounting flange to which the probe module 14 attaches.This approach may enable the transducer assembly to be mounted to acustom-fitted fixture 426 that conforms to the patient anatomy.

In another implementation, and turning to FIG. 18, a thermoformable(e.g., thermomoldable) custom-fitted plate may be formed, such as usinga thermoformable substrate, in accordance with the process flowdescribed. In one such example, a patient removes any interveningclothing and assumes the position to be adopted during a therapysession. A thermoformable sheet (e.g., thermos-moldable substrate 480),such as a thermoformable foam or polymer sheet, is heated (step 484) toform a conformable substrate 488, which is then placed over the therapytarget area (step 492) and pressure applied to confirm the compliantthermoformable sheet to the underlying anatomy. In such an embodiment,the patient contact time may be five minutes or less). In oneembodiment, the substrate (e.g., sheet) has an opening (e.g., centralwindow) exposing the therapy target area, and is surrounded by apressure sensitive adhesive. The therapy transducer mounting assembly(e.g., probe mounting plate 496) is bonded to this perimeter of adhesive(step 500) to form a mounting assembly 504. While the substrate is stillconformable, a probe module 14 having a therapy transducer is introduced(step 508) to the mounting assembly 504 and manipulated (step 512) toacquire the anatomical target. The patient remains in the therapy bodyposition while the substrate is allowed to cool (step 516) and becomerigid, forming a solid mount for the transducer assembly in the form ofa custom-fitted plate 520 that conforms to the body of the patient. Abelt, garment, or other mechanism may then be used to secure thecustom-fitted plate 520 to the patient for a therapy session.

Turning to FIG. 19, in a further embodiment, a material having an unset(flowable or moldable) state and a set (solid) state may be used to forman impression of the body of the patient at the site where thetransducers 20 will contact the patient. By way of example, in oneimplementation quick curing two-part silicone may be employed as aliquid casting material in conjunction with a perimeter wall (e.g.,adhesive foam sealing ring 464) to limit the area of the casting.Alternatively, in another embodiment, the casting material may beplaster, expanding foam (e.g., fast curing foam in a bag), or a similarmaterial that is moldable when not set. Turning to FIG. 19, this may berepresented as generalized steps of a process flow as illustrated. Inthis example, the sealing ring 464 (i.e., perimeter wall) is applied(step 542) at the target therapy area while the patient is in thetherapy position in order to define a region for forming a casting. Thesealing ring 464 may be an adhesive backed foam structure that stickstemporarily to the therapy target area. An example of one such sealingring 464 is shown in FIG. 20.

The unset casting material 550 (e.g., uncured silicone, unset plaster)may be poured (step 552) into the area defined by the sealing ring 464and conform to the patient anatomy in this defined region so as to forma molded body impression 460 when set. The sealing ring 464 blocks theflow of the unset casting material 550 and allows for sufficient height(e.g., thickness) of the casting material to build up to form thedesired molded body impression 460, an example of which is shown in FIG.21. In some contexts pressure may be applied to the casting material toconform it to the patient, such as in an implementation where thecasting material is an expanding foam in a bag and the bag is pressedagainst the patient anatomy. In certain implementations, the castingmaterial is allowed to set for 7 to 10 minutes (e.g., for silicone orplaster) or 5 minutes or less (e.g., for expanding foam).

A transducer mounting plate 454 (e.g., a rigid transducer integrationplate) may be placed (step 560) on or into the unset casting material550. In one embodiment, the transducer mounting plate 454 may havemultiple anchors or bosses to mechanically lock the mounting plate 454to the casting material after the casting material is cured (i.e., set).An example of such a transducer mounting plate 454A having anchors 580is shown in FIG. 22A. Alternatively, as shown in FIG. 22B, thetransducer mounting plate 454B could include multiple holes 582throughout to allow casting material (e.g., silicone) to flow throughand submerge the transducer mounting plate 454B, embedding the platewithin the casting material when set.

As noted above, with the transducer mounting in position, the castingmaterial may be set (step 570) using the appropriate environmentaltrigger(s) (such as temperature, time, chemical reaction, exposure tocertain wavelengths of radiation (e.g., ultraviolet light) so as tosolidify the casting material to the transducer mounting plate 454 andto provide a patient-conformable surface opposite the area provided forattachment of the probe module 14. In this manner, a custom-fitted plate520 may be fabricated, which may be used with a belt or other attachmentmechanism to secure to the patient, thereby allowing the probe module 14to attach to the patient using a fixture custom-fitted to the patient.The relationship between the transducer mounting plate 454, probe module14, molded body impression 460, and sealing ring 464 is shown in anexploded view in FIG. 23.

By way of example, for the respective examples described herein relatedto fabrication and use of a custom-fitted plate 520 for placement of aprobe module 14 on a patient, various belts, vests, or other garments asdescribed herein may be used to position and hold the custom-fittedplate 520 to the patient with the probe module 14 attached. By way ofexample, various belt assemblies may be used to hold and position thecustom-fitted plate 520 (and attached probe module 14) for daily orperiodic therapy. As discussed herein, the belt may be adjustable andcould consist of a simple strap around the torso, multiple straps thatcould engage shoulders or other anatomical anchor points, or a full vestthat contacts the full chest, sides, and back of the patient. Asdiscussed herein, fit and adjustment of such a belt (or otherpositioning device) may be accomplished using systems or techniques asdiscussed herein. For example, tensioning of the device may beaccomplished using elastic material, a ratcheting and locking cabletensioning system, pumped inflation, or lacing. Hook and loop fasteningcould be used to lock the belt into place after tensioning an elasticmaterial. Further, the belt, vest, or other garment type device mayincorporate rigid structures (e.g., straight or curved plates, rods, andso forth) which may help serve as mounting points for a probe module 14or custom-fitted plate 520 and/or may help conform and “lock” tospecific anatomical features (e.g., the ribs, spine, sides of the torso,and so forth). In such an implementation, such features may help preventmovement of the belt, vest, or other garment relative to the body oncesecured in place.

The preceding generally relates techniques for fabricating a customized,patient specific interface for probe module to contact a target area ofpatient anatomy (e.g., a custom-fitted plate 520. However it should alsobe appreciated that the custom-fitted structure may be more substantialor encompassing, such as a larger structure customized to fit to andconfirm with a larger anatomic region, such as fitted to a torso, arm,leg, and so forth. Such custom-fitted structure may include, asdescribed above, a region to which the probe module 14 is fitted ormight otherwise be attached. In such approaches similar techniques asdescribed herein may be employed to fabricate the customized structure,such as the use of formable or thermally pliable plastics or polymers(e.g., a thermoformable foam sheet or polymer), casting techniques usinga settable material (e.g., silicone, plaster, expanding foam, and soforth) that sets subsequent to expansion, and so forth.

In addition to the above described approaches related to techniques forholding a probe module 14 to a target region of a patient in arepeatable and reliable manner, a further aspect of the presenttechnique allows for full or partial target immobilization in order tofacilitate non-clinical therapy applications. By way of example, targetdrift during neuromodulation therapy may occur due to respiration orpatient movement. Such drift may make it difficult to maintaintransducer alignment with the anatomic target.

To avoid such target drift, in some embodiments external pressure orconstraints may be employed to reduce the extent of patient motion oreliminate patient motion with respect to the target treatment region andthe point of contact of the probe module 14. In such contexts a probemodule may be employed having less electronic steering capability, assuch electronic steering may not be required to compensate for targetdrift.

By way of example, external pressure can be applied by pressing thetransducer inward towards the target and a rigid clamp mechanism may beemployed to exert the force required to locally displace the tissuebetween the transducer and target anatomy. The distance from transducerto target anatomy is also reduced as this tissue is displaced, allowingtransducers of shorter focal depth to reach deeper target areas. A beltor other probe positioning structure as discussed herein may also beused to apply more general compression to the area, which would reducetarget movement.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims, and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they have structural elementsthat do not differ from the literal language of the claims, or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal languages of the claims.

1. A wearable device, comprising: an ultrasound probe, wherein, theultrasound probe comprises one or more ultrasound transducers, whereinone or more of the ultrasound transducers are configured to emit atherapy beam and one or more of the ultrasound transducers areconfigured to emit an imaging beam; and a positioning structureconfigured to hold the ultrasound probe.
 2. The wearable device of claim1, wherein the same one or more ultrasound transducers emit the imagingbeam and the therapy beam.
 3. The wearable device of claim 1, whereinthe therapy beam is in a frequency range of 0.2 MHz to 2 MHz.
 4. Thewearable device of claim 1, wherein the positioning structure comprisesone or more adjustable fitting features.
 5. The wearable device of claim4, wherein the adjustable fitting features comprise one or more ofstraps, clips, ratchets, pull cords, lacing tensioners, or inflatablestructures.
 6. The wearable device of claim 5, further comprising aprobe coupling structure provided configured to receive and securelyhold the ultrasound probe.
 7. The wearable device of claim 5, furthercomprising one or more sensors configured to measure and guide aninitial fitting operation and/or subsequent applications of thepositioning structure prior to use.
 8. The wearable device of claim 7,wherein the one or more sensors comprise one or more of an inertialmeasurement unit (IMU), a contact force sensor, or a tension or strainsensor.
 9. The wearable device of claim 5, wherein sensor data generatedby the one or more sensors is used to guide adjustment of one or moreadjustable fitting features of the wearable device to facilitateadjustment of position and orientation of the ultrasound probe.
 10. Thewearable device of claim 5, wherein sensor data generated by the one ormore sensors is provided as an input to one or more automation routinesthat, during operation automatically adjust one or more adjustablefitting features of the wearable device to facilitate adjustment ofposition and orientation of the ultrasound probe.
 11. The wearabledevice of claim 1, wherein the positioning structure comprises a probeholder comprising a movable frame configured allow movement of theultrasound probe in one or more degrees of freedom.
 12. The wearabledevice of claim 1, wherein the positioning structure comprises a probeholder comprising a spherical joint configured to allow movement of theultrasound probe in one or more of a rock, a tilt, or a spin angularorientation.
 13. The wearable device of claim 1, wherein the positioningstructure comprises a probe holder comprising one or more lockingmechanisms that lock the ultrasound probe in a fixed position and/ororientation with respect to the positioning structure.
 14. The wearabledevice of claim 13, wherein the one or more locking mechanisms areconfigured as part of a fitting operation and are to remain engaged andunaltered in subsequent therapy sessions for a given patient.
 15. Thewearable device of claim 1, further comprising a probe cap affixed tothe ultrasound probe, wherein the probe cap determines one or more of anangular orientation, an attenuation characteristic, or a geometry orfocusing characteristic of the ultrasound probe when applied.
 16. Thewearable device of claim 15, wherein one or more of the ultrasoundprobe, the positioning structure, or the probe cap are modular swappablestructures that can be swapped with corresponding modular structures.17. The wearable device of claim 1, wherein the positioning structure isconfigured to conformally fit to a patient.
 18. A method of configuringa wearable device, comprising: applying the wearable device to asubject, wherein an ultrasound probe is coupled to a positioningstructure of the wearable device and wherein the ultrasound probecomprises one or more ultrasound transducers, wherein one or more of theultrasound transducers are configured to emit a therapy beam and one ormore of the ultrasound transducers are configured to emit an imagingbeam; adjusting one or more of the wearable device, the positioningstructure, or the ultrasound probe with respect to an anatomic targetregion of the subject; determining one or more fitting parameters of thewearable device, the positioning structure, or the ultrasound probe whenaligned to the anatomic target region; and saving the one or moreparameters for use when the wearable device is subsequently applied tothe subject for a therapy session.
 19. The method of claim 18, whereinsaving the one or more parameters comprises locking the ultrasound probein place using a locking mechanism so as to prevent subsequentadjustment to one or both of the position or orientation of theultrasound probe.
 20. The method of claim 19, wherein the lockingmechanism is provided as part of a probe holder that allows movement ofthe ultrasound probe in x-, y-, and z-dimensions and orientation angles,wherein the locking mechanism locks the ultrasound probe into positionin the x-, y-, and z-dimensions as well as locking an orientation of theultrasound probe.
 21. The method of claim 18, wherein, while performingthe step of adjusting, guidance is received based on one or both ofimage data or sensor data.